| Efficacy, Safety, Tolerability And Actual Use Study Of Bococizumab And An Autoinjector (Pre-Filled Pen) In Subjects With Hyperlipidemia Or Dyslipidemia |
| A 12 Week, Phase 3, Double-blind, Randomized, Placebo-controlled, Parallel Group Study To Assess The Efficacy, Safety, Tolerability And Actual Use Of Bococizumab And An Autoinjector (Pre-filled Pen) In Subjects With Primary Hyperlipidemia Or Mixed Dyslipidemia |
| This study is a multicenter, randomized study in subjects with high cholesterol receiving statins to assess the efficacy to lower LDL-C, the safety, tolerability and actual use of bococizumab and an autoinjector (pre-filled pen). |
| Not Provided |
| Interventional |
| Phase 3 |
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment |
| Hyperlipidemia |
- Biological: Bococizumab 150mg
Bococizumab autoinjector (pre-filled pen) combination Product. 150mg every 2 weeks for 10 weeks, subcutaneous injection.
- Biological: Bococizumab 75mg
Bococizumab autoinjector (pre-filled pen) combination Product. 75mg every 2 weeks for 10 weeks, subcutaneous injection.
- Biological: Bococizumab 150mg placebo
Bococizumab placebo autoinjector (pre-filled pen) combination Product. 150mg placebo every 2 weeks for 10 weeks, subcutaneous injection.
- Biological: Bococizumab 75mg placebo
Bococizumab placebo autoinjector (pre-filled pen) combination product. 75mg placebo every 2 weeks for 10 weeks, subcutaneous injection.
|
- Experimental: Bococizumab 150mg
Bococizumab 150mg autoinjector (pre-filled pen)
Intervention: Biological: Bococizumab 150mg
- Experimental: Bococizumab 75mg
Bococizumab 75mg autoinjector (pre-filled pen)
Intervention: Biological: Bococizumab 75mg
- Placebo Comparator: Bococizumab 150mg placebo
Bococizumab 150mg placebo autoinjector (pre-filled pen)
Intervention: Biological: Bococizumab 150mg placebo
- Placebo Comparator: Bococizumab 75mg placebo
Bococizumab 75mg autoinjector (pre-filled pen)
Intervention: Biological: Bococizumab 75mg placebo
|
| Ridker PM, Tardif JC, Amarenco P, Duggan W, Glynn RJ, Jukema JW, Kastelein JJP, Kim AM, Koenig W, Nissen S, Revkin J, Rose LM, Santos RD, Schwartz PF, Shear CL, Yunis C; SPIRE Investigators. Lipid-Reduction Variability and Antidrug-Antibody Formation with Bococizumab. N Engl J Med. 2017 Apr 20;376(16):1517-1526. doi: 10.1056/NEJMoa1614062. Epub 2017 Mar 17. |
| |
| Completed |
| 299 |
| February 2016 |
| February 2016 (Final data collection date for primary outcome measure) |
|
Inclusion Criteria:
- Treated with a statin - Fasting LDL-C >=70mg/dL and triglycerides <=400mg/dL
Exclusion Criteria:
- Pregnant or breastfeeding females - Cardiovascular or cerebrovascular event or procedures during the past 90 days - Congestive heart failure NYHA class IV - Poorly controlled hypertension
|
| Sexes Eligible for Study: |
All |
|
| 18 Years and older (Adult, Senior) |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States |
| |
| |
| NCT02458287 |
B1481046
SPIRE-AI ( Other Identifier: Alias Study Number ) |
| No |
| Studies a U.S. FDA-regulated Drug Product: |
Yes |
| Studies a U.S. FDA-regulated Device Product: |
No |
|
| Not Provided |
| Pfizer |
| Pfizer |
| Not Provided |
| Study Director: |
Pfizer CT.gov Call Center |
Pfizer |
|
| Pfizer |
| March 2017 |
